NMO Spectrum DisorderPhase 4NCT05896605
Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder
A Phase 4 study testing Azathioprine in people with NMO Spectrum Disorder and Azathioprine Adverse Reaction, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
Background: The pathogenesis of NMOSD has been linked to the cytokines interleukins (IL) -6, NOD-, LRR-and pyrin domain-containing 3 (NLRP3) and IL-18 that contribute to development of inflammatory reactionsmay. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- NMO Spectrum Disorder, Azathioprine Adverse Reaction
- What is being tested?
- Azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with NMOSD met the international consensus diagnostic criteria for NMOSD published in 2015. Before medication, TPMT activity was normal.
Who cannot join
- Patients with fever, infection, or patients with other autoimmune diseases, uncontrolled malignancies, and other chronic diseases were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The pathogenesis of NMOSD has been linked to the cytokines interleukins (IL) -6, NOD-, LRR-and pyrin domain-containing 3 (NLRP3) and IL-18 that contribute to development of inflammatory reactionsmay. Although azathioprine (AZA) is efficacious in preventing NMOSD recurrence, it may have adverse effects (AEs) maybe related to the plasma concentrations.
Objective: We would monitor the blood concentrations of AZA in NMOSD, and their relationship with cytokines, severity, efficacy, and safety range of the drug.
Methods: A total of 53 NMOSD patients were included in the study, which included 20 patients who had received AZA treatment within 1 month, and 16 patients who had received AZA treatment within 6 months, as well as 17 patients who had received AZA treatment at least 12 months. The patient's immunotherapy regimen was low-dose hormone combined with AZA. AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. The following clinical data were collected: gender, age, clinical symptoms, EDSS score, number of recurrences and AEs, etc. Healthy controls (HC) comprised 10 individuals. AZA metabolite concentrations 6-thioguaninenucleotides (6-TGN) and 6-methylmercaptopurine nucleotides (6-MMPN) were measured by High-performance liquid chromatography (HPLC). Levels of IL-6, NLRP3 and IL-18 were measured by Enzyme-linked immunosorbent assay (ELISA).
Read the detailed description
A total of 53 NMOSD patients were recruited from Neurology Department of the First Affiliated Hospital of Guangxi Medical University.According to the duration of AZA treatment, 20 patients were divided into 1 month after AZA treatment, 16 patients in 6 months after AZA treatment and 17 patients over 12 months after AZA treatment. Clinical data of patients were collected, including: gender, age, time of first onset, time of medication, clinical symptoms, number of recurrence, EDSS score, serum and cerebrospinal fluid AQP 4-IgG titers, imaging results, rheumatic immunity-related autoimmune antibodies, comorbidities, related adverse drug reactions, etc. Ten healthy volunteers with physical examination in our hospital were selected as the healthy control (HC) group.Blood (5ml) was collected from peripheral veins of patients and healthy volunteers.
- Being tested
- Azathioprine
- Keywords
- NMOSD, AZA, 6-TGN, 6-MMPN, IL-6, NLRP3, IL-18
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
Also called Azathioprine Tablets
Before medication, TPMT activity was normal, and AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid.
| Study group | Role | What they receive |
|---|---|---|
| 1 month after AZA treatment | Active comparator | Before medication, TPMT activity was normal, and azathioprine was started at small doses and added every two weeks after no adverse effects, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. Low-dose hormone therapy was administered to all patients simultaneously.Blood (5ml) was collected from peripheral veins in 1 month after AZA treatment. Receives: Drug: Azathioprine |
| 6 months after AZA treatment | Active comparator | Before medication, TPMT activity was normal, and azathioprine was started at small doses and added every two weeks after no adverse effects, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. Low-dose hormone therapy was administered to all patients simultaneously.Blood (5ml) was collected from peripheral veins in 6 months after AZA treatment. Receives: Drug: Azathioprine |
| over 1 year after AZA treatment | Active comparator | Before medication, TPMT activity was normal, and azathioprine was started at small doses and added every two weeks after no adverse effects, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. Low-dose hormone therapy was administered to all patients simultaneously.Blood (5ml) was collected from peripheral veins over 1 year after AZA treatment. Receives: Drug: Azathioprine |
| healthy control | No intervention | Ten healthy volunteers with physical examination in our hospital were selected as the healthy control (HC) group. Serum samples from healthy controls were collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentrations of 6-TGN and 6-MMPN in NMOSD patients
The mean 6-TGN concentrations and 6-MMPN concentrations in 1 month after AZA treatment were tested by HPLC
Measured: 1 month
The concentrations of 6-TGN and 6-MMPN in NMOSD patients
The mean 6-TGN concentrations and 6-MMPN concentrations in 6 months after AZA treatment were tested by HPLC.
Measured: 6 months
The concentrations of 6-TGN and 6-MMPN in NMOSD patients
The mean 6-TGN concentrations and 6-MMPN concentrations in over 12 months after AZA treatment were tested by HPLC.
Measured: 12 months
Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC
The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.
Measured: 1 month
Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC
The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.
Measured: 6 months
Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC
The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMO Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingmeng Huang, First Affiliated Hospital of Guangxi Medical University
- Investigators
- Yulan Tang, Study director, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896605
- Sponsor's protocol ID
- qingmenghuang
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05896605
- Acronym / sponsor ID
- qingmenghuang
- Keywords
- NMOSD, AZA, 6-TGN, 6-MMPN, IL-6, NLRP3, IL-18
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The pathogenesis of NMOSD has been linked to the cytokines interleukins (IL) -6, NOD-, LRR-and pyrin domain-containing 3 (NLRP3) and IL-18 that contribute to development of inflammatory reactionsmay. Although azathioprine (AZA) is efficacious in preventing NMOSD recurrence, it may have adverse effects (AEs) maybe related to the plasma concentrations.
Objective: We would monitor the blood concentrations of AZA in NMOSD, and their relationship with cytokines, severity, efficacy, and safety range of the drug.
Methods: A total of 53 NMOSD patients were included in the study, which included 20 patients who had received AZA treatment within 1 month, and 16 patients who had received AZA treatment within 6 months, as well as 17 patients who had received AZA treatment at least 12 months. The patient's immunotherapy regimen was low-dose hormone combined with AZA. AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. The following clinical data were collected: gender, age, clinical symptoms, EDSS score, number of recurrences and AEs, etc. Healthy controls (HC) comprised 10 individuals. AZA metabolite concentrations 6-thioguaninenucleotides (6-TGN) and 6-methylmercaptopurine nucleotides (6-MMPN) were measured by High-performance liquid chromatography (HPLC). Levels of IL-6, NLRP3 and IL-18 were measured by Enzyme-linked immunosorbent assay (ELISA).
Detailed description
A total of 53 NMOSD patients were recruited from Neurology Department of the First Affiliated Hospital of Guangxi Medical University.According to the duration of AZA treatment, 20 patients were divided into 1 month after AZA treatment, 16 patients in 6 months after AZA treatment and 17 patients over 12 months after AZA treatment. Clinical data of patients were collected, including: gender, age, time of first onset, time of medication, clinical symptoms, number of recurrence, EDSS score, serum and cerebrospinal fluid AQP 4-IgG titers, imaging results, rheumatic immunity-related autoimmune antibodies, comorbidities, related adverse drug reactions, etc. Ten healthy volunteers with physical examination in our hospital were selected as the healthy control (HC) group.Blood (5ml) was collected from peripheral veins of patients and healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 month after AZA treatment | Active comparator | Drug: AzathioprineBefore medication, TPMT activity was normal, and azathioprine was started at small doses and added every two weeks after no adverse effects, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. Low-dose hormone therapy was administered to all patients simultaneously.Blood (5ml) was collected from peripheral veins in 1 month after AZA treatment. |
| 6 months after AZA treatment | Active comparator | Drug: AzathioprineBefore medication, TPMT activity was normal, and azathioprine was started at small doses and added every two weeks after no adverse effects, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. Low-dose hormone therapy was administered to all patients simultaneously.Blood (5ml) was collected from peripheral veins in 6 months after AZA treatment. |
| over 1 year after AZA treatment | Active comparator | Drug: AzathioprineBefore medication, TPMT activity was normal, and azathioprine was started at small doses and added every two weeks after no adverse effects, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. Low-dose hormone therapy was administered to all patients simultaneously.Blood (5ml) was collected from peripheral veins over 1 year after AZA treatment. |
| healthy control | No intervention | –Ten healthy volunteers with physical examination in our hospital were selected as the healthy control (HC) group. Serum samples from healthy controls were collected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with NMOSD met the international consensus diagnostic criteria for NMOSD published in 2015. Before medication, TPMT activity was normal.
Key exclusion criteria (1 listed)
- Patients with fever, infection, or patients with other autoimmune diseases, uncontrolled malignancies, and other chronic diseases were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzathioprineAlso: Azathioprine TabletsBefore medication, TPMT activity was normal, and AZA was started at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg bid for two weeks, and maintained at 50mg tid. | Drug | 1 month after AZA treatment, 6 months after AZA treatment, over 1 year after AZA treatment |
Primary outcome
The concentrations of 6-TGN and 6-MMPN in NMOSD patients
Time frame: 1 month
The mean 6-TGN concentrations and 6-MMPN concentrations in 1 month after AZA treatment were tested by HPLC
The concentrations of 6-TGN and 6-MMPN in NMOSD patients
Time frame: 6 months
The mean 6-TGN concentrations and 6-MMPN concentrations in 6 months after AZA treatment were tested by HPLC.
The concentrations of 6-TGN and 6-MMPN in NMOSD patients
Time frame: 12 months
The mean 6-TGN concentrations and 6-MMPN concentrations in over 12 months after AZA treatment were tested by HPLC.
Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC
Time frame: 1 month
The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.
Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC
Time frame: 6 months
The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.
Serum levels of IL-6, NLRP3 and IL-18 in NMOSD patients and HC
Time frame: 12 months
The levels of IL-6, IL-18, and NLRP 3 inflammasome were measured in the enzyme-linked immunoassay kit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulan Tang study director
First Affiliated Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azathioprine in people with NMO Spectrum Disorder and Azathioprine Adverse Reaction, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentrations of 6-TGN and 6-MMPN in NMOSD patients (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.